先健科技(01302.HK):FIM臨牀試驗結果初步表明IBS®冠脈支架在簡單原發性冠脈病變中具有良好的中期安全有效性
格隆匯11月9日丨先健科技(01302.HK)宣佈,於2021年11月5日,集團自主研發的IBS®可吸收藥物洗脱冠脈支架系統("IBS®冠脈支架")於2021年美國經導管心血管治療學術會議上由高潤霖院士公佈了FIM臨牀試驗兩年期隨訪結果,此為全球首個鐵基可吸收支架的臨牀試驗。
FIM臨牀試驗結果初步表明IBS®冠脈支架在簡單原發性冠脈病變中具有良好的中期安全有效性。兩年回訪數據顯示無死亡、心梗以及血栓案例,顯示了良好的安全性,其有效性指標也與其他主流永久支架相當。該臨牀試驗手術成功率高達100%,兩年已基本到達降解晚期且降解過程中無貼壁不良現象。
IBS®冠脈支架的中國確證性臨牀已於2021年8月25日獲批,隨着後續臨牀試驗的穩步推進,將會有更多的循證醫學證據進一步證實產品的安全性和有效性,並將在該產品成功上市後,為全球冠心病患者帶來前所未有的治療方式。
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